Delighted and Proud

debGuest Post from Deborah L. Benzil, MD, FACS, FAANS
Chair, AANS/CNS Communications and Public Relations Committee
Mount Kismo Medical Group
Columbia University Medical Center
Mt Kisco, New York

Having a career as a neurosurgeon is incredibly rewarding. Perhaps even more gratifying is being a part of such a remarkable community. While neurosurgeons represent only one percent of the nation’s physicians, our impact on patients and their loved ones is disproportionately large. In the arena of pain, Neurosurgery Blog’s focus on pain is just one poignant example. For more than a century, neurosurgeons have played a pivotal role in defining and understanding the science of pain. My subspecialty is continuing to contribute to determining the etiology of the leading cause of disabling pain (neck and back pain), developing innovative surgical interventions for these conditions, as well as highly effective surgical treatments for patients with chronic, intractable pain. You would have to have your head under an enormous rock not to know of America’s opioid crisis, but it’s important to point out that the pain crisis is so much more complicated than this cliché allows. The goal of our content during this pain focus has been to explore the nuances of this growing challenge. These include:

pain 2Neurosurgeons have unique and crucial information on this topic that the public needs to know. Furthermore, it’s important to tell all sides of the pain equation and what neurosurgeons experience on the frontlines treating pain, including:

  • Someone who has died or suffered the ravages of opioid addiction;
  • Numerous patients suffering acute or chronic pain from a neurosurgical condition (degenerative spine, brain and spine tumors, infections, peripheral nerve injuries);
  • That narcotics can be essential for patients to achieve the desired quality outcomes in the post-operative setting;
  • Alternative neurosurgical interventions derived through research and innovation are highly efficacious in treating many pain conditions; and
  • Ongoing advocacy and appropriate policy to address the real and complex issues of pain, narcotics and addiction remain critically important.

Neurosurgery Blog will continue to tackle the difficult, but important, issues facing so many patients and their families. Shortly, we will turn our attention from pain into a laser focus month on spine. As the American population continues to age, spine issues will remain as a primary cause of pain and disability, which has a substantial economic impact on the country. As with pain, neurosurgeons are leading the way in addressing this critical topic.

“Of pain you could wish only one thing: that it should stop. Nothing in the world was so bad as physical pain. In the face of pain there are no heroes.”George Orwell

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The Rush to Limit Opioid Prescribing

winfreeChristopher J. Winfree, MD, FAANS
Department of Neurological Surgery, Columbia University
New York, NY

Ever since the Affordable Care Act (ACA) was passed in 2010, there has been increased attention paid to the use of opioids to treat chronic pain in America. Much of this has been in response to a worsening opioid crisis for patients and non-patients have had access to increasing supply of powerful opioid pain-relieving medications. Ready access to these drugs has enabled patients, and sometimes their family members, to become addicted to these medications. This commonly leads to heroin or synthetic opioid abuse. It is important to note that more patients are dying of opioid overdose than of car accidents, which is a pretty remarkable statistic. At this time, the Trump Administration is considering declaring a national emergency over the developing opioid crisis in America.

op3Given that this crisis is at least partially due to the abundance of readily-available and powerful opioid medications, efforts to reduce the illicit use of opioids as well as their overall availability seem reasonable. Efforts to limit the use of opioids to clinical situations that warrant their use and minimize access to these drugs to patients who do not need them should be applauded. The routine use of prescription drug monitoring programs and opioid contracts for chronic opioid users are examples of laudable efforts to optimize the prescribing of opioids.

Additionally, several states have enacted legislation limiting the prescribing of opioids for acute pain to short periods of time. Arizona, New York, Delaware, and Pennsylvania are examples of states that have a seven-day limit. New Jersey has the strictest law, allowing only a five day supply of opioids. Generally, the limitations do not apply to patients with chronic pain, cancer pain, or in a palliative care program. Pennsylvania allows for longer-term prescribing than seven days if the treating physician documents the medical necessity of the increased opioid prescription and the absence of non-opioid alternatives. Earlier this year, Sens. John McCain (R-Ariz.) and Kirsten Gillibrand (D-N.Y.) coauthored S. 892, the Opioid Addiction Prevention Act, which would restrict postoperative pain medications nationwide to a seven day supply, similar to the state laws already in place. Reps. Phil Roe, MD (R-Tenn.) and Ann Kuster (D-N.H.) have introduced similar legislation (which is more flexible and allows a 10-day supply) by the same name, H.R. 3964, in the House of Representatives. No action has yet been taken on these bills.

In theory, such legislation makes sense if the aim is to limit the supply of new drugs to the general population of opioid-naïve patients presenting to the emergency room with a new, acute pain syndrome. In most cases, a one week supply of opioid medication is sufficient to either adequately treat the patient through the pain episode, or at least treat them until they can follow-up with their outpatient physician for further management.

Unfortunately, this legislation creates an unacceptable hardship for a subset of neurosurgical patients who require opioid medications to treat acute pain that is expected to last longer than one week. Patients who undergo complex spine surgery, such as fusions and scoliosis reconstructions, will almost always require longer-term opioid administration, sometimes lasting several weeks. Head trauma patients who also require management of other painful orthopedic or abdominopelvic trauma often need opioid pain medication lasting longer than one week. Given that all opioid prescriptions require a face-to-face visit with the prescriber, the expectation that a convalescing polytrauma or scoliosis patient will be able to make weekly visits to their physician for an opioid prescription is ridiculous. What will happen in many cases instead, is that patients will not make these appointments and their pain will go undertreated. This will have a detrimental effect on outcomes, as the patient in severe pain will be less likely to mobilize and participate in therapy. A blanket limitation of all opioid prescriptions for acute pain for five to seven days will no doubt hurt many of our neurosurgical patients.

To protect our acute pain patients that require opioids for longer than one week, the AANS, CNS and the AANS/CNS Joint Section on Pain recently sent a letter to Sens. McCain and Gillibrand requesting that the bill allow exceptions for these patients. This should not be a blanket exception weakening the law, but an exception only in specific clinical circumstances that the physician deems appropriate for patients requiring more aggressive opioid management. Such an exemption would be similar to that present in Pennsylvania opioid prescribing law, which allows longer prescriptions than one week when clinically appropriate and sufficiently documented by the treating physician. Our hope is that such an exemption will ensure that our neurosurgical patients who undergo complicated and painful surgical procedures can continue to access vital post-operative pain management strategies.

State and Federal governments have made it clear that restricting opioid prescribing is an essential strategy in reducing the opioid crisis in America. This will hopefully reduce the vast amount of unneeded opioid medications in circulation. As physicians in general, and neurosurgeons specifically, we need to remain active in this legislative process to ensure that our patients continue to have access to the medically-necessary opioids to treat their severe pain, and not be improperly denied access to these crucial medications when most needed.

Editor’s Note: We encourage everyone to join the conversation online by using the hashtag #painfacts.

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DoD/VA Lead the Way in the Opioid Crisis

hs4Christopher Spevak, MD, MPH, JD (left)
Chair of the DoD/VA Opioid Clinical Practice Guideline
Medical officer at Walter Reed National Military Medical Center where he directs the National Capital Region Opioid Safety Program
Bethesda, MD

Randy Bell, MD, FAANS, MC, USN (right)
Associate professor and chief of neurosurgery at Walter Reed National Military Medical Center AANS/CNS Joint Committee of Military Neurosurgery
Bethesda, MD

The views expressed in this article are those of the authors and do not reflect the official policy of the Department of Army/Navy/Air Force, Department of Defense, or U.S. Government.

Everyone knows that the problem of pain is on the rise as is opioid prescribing (20 percent of visits in 2010 compared to 11 percent in 2000)(1) matched by a parallel increase in morbidity, mortality, opioid-related overdose death rates, and substance abuse treatment admissions (2). The U.S. Department of Veterans Affairs (VA) and the U.S. Department of Defense (DoD) are equally impacted by this epidemic (4) where it has become a critical issue. The response to this crisis began in October 2015 with work on an evidence-based clinical practice guideline (CPG) for opioid therapy in treating chronic pain to replace the previous CPG from 2010. In the civilian world, such policy development becomes mired in political wrangling, territorial disputes and issues related to competition between facilities and physicians. However, the DoD/VA has the unique capacity to respond quickly and efficiently to initiate an action plan based on the best data available. After time for implementation and analysis of effectiveness, the lessons learned will help all understand how to better tackle the issues of pain, opioid use and abuse.

The 2010 CPG for the Management of Opioid Therapy for Chronic Pain was the foundation for the DoD/VA endeavor, considering the specific needs of the DoD and VA and new evidence regarding prescribing opioid medication for non-end-of-life related chronic pain. In addition, a patient focus group explored patient perspectives on a set of topics related to management of opioid therapy (OT) in the VA and DoD health care systems.

Recommendations were developed utilizing the quality standards and process in the “Guideline for Guidelines” published by the Evidence-Based Practice Working Group (EBPWG) (5). At the start of the guideline development, all team members were required to submit conflict-of-interest (COI) disclosure statements for relationships in the prior 24 months. Verbal affirmations of no COI were used periodically during the development process and web-based surveillance (e.g. ProPublica) was used to monitor for potential COIs. No work group members reported relationships and/or affiliations which had the potential to introduce bias, and none were found throughout the development of the guidelines.

The guidelines panel focused on a small number of topics considered to be the most clinically important and relevant with respect to long-term opioid therapy (LOT) for chronic pain, including:

  • Investigating how LOT compares to alternative pain modalities with regard to effectiveness and safety;
  • Evaluating the effectiveness and safety of various opioid formulations;
  • Which factors increase the risk of developing misuse or opioid use disorder;
  • Delineating which medical or mental health conditions are absolute or relative contraindications to prescribing LOT;
  • Effectiveness of risk mitigation strategies; and
  • Safety and efficacy of both treatment of Opioid Use Disorder (OUD) and different tapering strategies and schedules.

The CPG focuses on opioid therapy implementation while promoting robust risk reduction resulting in the development of four one-page algorithms which:

  • Provide recommendations on determination of appropriateness for opioid therapy; and
  • Stress initial utilization of non-pharmacologic and non-opioid pharmacologic therapies over opioid therapy for chronic pain.

To view Table 1 which summarizes all 16 recommendations, click here. Additionally, the full guideline can be found here.

The work group conducted a systematic search of peer-reviewed literature published through January 2016. Emphasis was placed on randomized trials, systematic reviews and meta-analyses of at least fair quality. The guideline panel rated recommendations using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) method (5,6,7).

The opioid crisis is upon us with enormous impact on active duty military and veterans as well as the civilian population. Quick to recognize the threat and respond to it, the DoD and VA have devoted considerable resources to addressing this epidemic and the results are clinical guidelines and approaches directly translatable to the civilian sector.

Editor’s note: The content of this post originally appeared in the AANS Neurosurgeon which is a publication of the American Association of Neurological Surgeons (AANS). We encourage everyone to join the conversation online by using the hashtag #painfacts.

References:

  1. Daubresse, M., Chang, H., Yu, Y., Viswanathan, S., Shah, N. D., Stafford, R. S., . . . Alexander, G. C. (2013). Ambulatory diagnosis and treatment of nonmalignant pain in the United States, 2000–2010. Medical Care, 51(10), 870-878.
  2. Centers for Disease Control and Prevention. (2011). Vital Signs: Overdoses of Prescription Opioid Pain Relievers – United States, 1999-2008. (2011, November 04).
  3. Dowell, D., Haegerich, T. M., & Chou, R. (2016). CDC guideline for prescribing opioids for chronic pain—United States, 2016. JAMA, 315(15), 1624.
  4. Rudd, R. A., Aleshire, N., Zibbell, J. E., & Gladden, R. M. (2016). Increases in drug and opioid overdose deaths-United States, 2000-2014. American Journal of Transplantation, 16(4), 1323-1327.
  5. Atkins, D., Best, D., Briss, P. A., Eccles, M., Falck-Ytter, Y., Flottorp, S., . . . Zaza, S. (2004). Grading quality of evidence and strength of recommendations. British Medical Journal, 328(754), 1490.
  6. Andrews, J., Guyatt, G., Oxman, A. D., Alderson, P., Dahm, P., Falck-Ytter, Y., . . . Schünemann, H. J. (2013). GRADE guidelines: 14. Going from evidence to recommendations: the significance and presentation of recommendations. Journal of Clinical Epidemiology, 66(7), 719-725.
  7. Andrews, J. C., Schünemann, H. J., Oxman, A. D., Pottie, K., Meerpohl, J. J., Coello, P. A., . . . Guyatt, G. (2013). GRADE guidelines: 15. Going from evidence to recommendation—determinants of a recommendations direction and strength. Journal of Clinical Epidemiology, 66(7), 726-735.
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